Aventis S.A. Rilutek®

FDA approved drug currently available

Rilutek® (Riluzole tablets), the first ALS drug ever approved by the FDA for the treatment of ALS, is on the market. This glutamate-blocking drug has been proven effective in well-controlled studies using survival as an end point. The most common side effects of Rilutek® are weakness, nausea, lung function decrease (not associated with a reduction in vital capacity), a mild liver disorder that is typically temporary and headache.

Gene therapy research programs in neurology within R-PR have been discontinued. There are no ALS clinical trials being conducted by R-PR at this time. However, future trials are not precluded.

In response to an article titled "New ALS Drug Riluzole Causes Liver Problems," published early in 1999 in Hepatitis Weekly, RP-R spokesperson Sheryl Williams provided the following statement: "Patients currently on or considering starting Riluzole should not be overly alarmed by this article. The possibility of adverse effects of Rilutek on the liver is well known and the physician who prescribes this drug is carefully advised of the potential problems.

The possibility of liver injury is discussed in the "Warnings" section of the product's labeling. Although that labeling does not specifically discuss hepatitis, it recommends that any patient being prescribed Rilutek receive tests of liver function prior to and during therapy. These tests will allow the physician to determine if the liver is reacting badly to Rilutek and to respond early if a problem occurs. …

The labeling also states: "Maximum increases in serum ALT usually occurred within 3 months after the start of Riluzole therapy and were usually transient when less than 5 times the upper limit of normal. In trials, even when ALT levels were less than 5 times the upper limit of normal, treatment continued and ALT levels usually returned to below 2 times the upper limit of normal within 2 to 6 months…."

For further information about Rilutek®, please call Aventis S.A. Drug Information Center at (800) 340-7502.

 

CHARCOT YOUNG INVESTIGATOR PRIZE FOR RESEARCH INTO AMYOTROPHIC LATERAL SCLEROSIS AND RELATED DISORDERS In collaboration with the Motor Neurone Disease Association, Aventis Pharma has contributed £20,000, to be awarded to an outstanding young investigator whose research is judged to have made a significant contribution to scientific understanding, or advances in patient treatment and care, in ALS and related motor neuron disorders. Applicants must be under 40 years at 31 December 2002 and engaged in active research in an appropriate academic institution or hospital. Applicants must submit a two-page summary of their achievements, accompanied by a curriculum vitae and copies of up to four relevant published manuscripts or articles. The award, to be used to support active research, will be presented at the 13th International Symposium on ALS/MND in Melbourne (17 - 19 November 2002). Applications (in duplicate) should be sent to Dr Belinda Cupid, MND Association, 10-15 Notre Dame Mews, Northampton NN1 2PR, United Kingdom (fax: +44 1604 638289; e-mail: belinda.cupid@mndassociation.org ) from whom further information can be obtained. The closing date for applications is Friday 2 August 2002.

Posted on October 17, 2008